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cardiome pharma corp (CRME) Details

Cardiome Pharma Corp., a biopharmaceutical company, is engaged in the development and commercialization of cardiovascular therapies that enhance the life and health of patients. It offers BRINAVESS (vernakalant IV), for conversion of recent onset atrial fibrillation to sinus rhythm in adults; and Aggrastat, a reversible GP IIb/IIIa inhibitor for use in acute coronary syndrome patients. The company’s pre-clinical research and development focuses on modulating cellular proteins (ion channels) that gate the movement of ions across the cell membrane to control various functions, including contraction of muscles, secretion from glands, and responses to foreign bodies and inflammation. It has operations in Canada, the United States, Switzerland, and the United Kingdom. The company was formerly known as Nortran Pharmaceuticals Inc. and changed its name to Cardiome Pharma Corp. in June 2001. Cardiome Pharma Corp. was founded in 1986 and is headquartered in Vancouver, Canada.

cardiome pharma corp (CRME) Key Developments

Cardiome Pharma Corp Enters into Development and Commercialization Agreement with Eddingpharm for Brinavess(TM) in China

Dec 19 14

Cardiome Pharma Corp. announced that one of its subsidiaries has entered into an agreement with Eddingpharm to develop and commercialize BRINAVESS(TM) in China, Taiwan, and Macau and re-launch BRINAVESS in Hong Kong. Eddingpharm will be responsible for any clinical trials and regulatory approvals required to commercialize BRINAVESS in the countries covered by the agreement. Under the terms of the agreement, Eddingpharm has agreed to an upfront payment of USD 1.0 million and specific annual commercial goals for BRINAVESS. Cardiome is also eligible to receive regulatory milestone payments of up to USD 3.0 million. Other financial details have not been disclosed.

Cardiome Pharma Corp. Enters into an Agreement with Pharmacare Limited to Sell and Distribute Brinavess(R) (Vernakalant Intravenous) in South Africa

Nov 17 14

Cardiome Pharma Corp. announced that an affiliate of the company has entered into an agreement with Pharmacare Limited to sell and distribute BRINAVESS(R) (vernakalant intravenous) exclusively in South Africa. Under the terms of the agreement, Aspen has agreed to specific annual commercial goals for BRINAVESS.

Cardiome Pharma Corp. announced results from a Phase 3 clinical study conducted with BRINAVESS(R) (vernakalant intravenous, RSD 1235) in the Asia-Pacific (A-P) region. The study was originally planned to recruit 615 patients, however the study was completed after randomising 123 patients. The study remained sufficiently powered and it achieved the primary endpoint, showing that of the 111 treated patients with recent-onset atrial fibrillation (AF) lasting 3 hours to 7 days, 53% of those receiving an IV dose of BRINAVESS converted to normal heart rhythm within 90 minutes, compared to 12% of placebo patients (95% CI; 23%, 58%, p<0.001). The A-P study data suggests that BRINAVESS was generally well-tolerated in the targeted patient population. In the 30 day interval following drug administration, serious adverse events occurred in 6 (11%) placebo patients and 7 (13%) patients dosed with BRINAVESS. Potentially drug-related serious adverse events occurred in 1(2%) patient receiving BRINAVESS. There were no cases of drug-related torsades de pointes, a well-characterized arrhythmia which is an occasional side effect of many current antiarrhythmic drugs. The A-P study was designed to investigate the safety and efficacy of intravenous BRINAVESS in patients with recent-onset atrial fibrillation lasting 3 hours to 7 days. The primary endpoint in A-P was conversion of recent-onset AF to normal heart rhythm for a period of at least 1 minute post-dosing within 90 minutes of the start of dosing. The study was initiated in August 2010, and was carried out in 35 centers in Korea, Taiwan, Hong Kong and India.

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